# K971439: Storz Microflow and Storz Standard Phacoemulsification Needles

- Pathway: 510(k) (Traditional)
- Applicant: Storz Instrument Co.
- Decided: Jun 17, 1997 after 60 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K943102 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954340: Storz Microflow Phacoemulsification Needle, Storz (1995) Summary page 2.
- K952259: Storz Microseal DP8030 & DP8045 Phacoemulsification Needles, Storz Instrument Co. (1995) Summary page 2.
- K943102: High Performance Tips, Surgin Surgical Instrumentation, Inc. (1994) Summary page 2.
- K946176: Storz Phacoemulsification Needles, Storz Instrument Co. (1995) Summary page 2.

## Indications for use
The Storz MicroFlow Plus, MicroFlow Plus Angled, and Standard Angled Phacoemulsification Needles are accessories to a phacoemulsification handpiece, intended for use in the ultrasonic surgical removal of the cataractous crystalline lens.

Source page: https://510kreport.com/device/K971439
Methodology: https://510kreport.com/methodology